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Swedish Match USA, Inc., MRTP Applications

On October 22, 2019, the FDA issued modified risk orders to Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), for the following snus smokeless tobacco products:

  • General Loose
  • General Dry Mint Portion Original Mini
  • General Portion Original Large
  • General Classic Blend Portion White Large-12ct
  • General Mint Portion White Large
  • General Nordic Mint Portion White Large-12ct
  • General Portion White Large
  • General Wintergreen Portion White Large

Updates to Application

  • On November 30, 2023, FDA filed for scientific review modified risk tobacco product (MRTP) application renewals submitted by Swedish Match USA for the General Snus products. The original MRTP orders are valid for a term of 5 years from the date of issuance. To continue marketing an MRTP after the term of an order, the company may submit an MRTP renewal application for FDA to determine that the product still satisfies the requirements in section 911. Renewal applications may cross-reference an applicant’s original MRTP as well as postmarket annual reports submitted in accordance with marketing order requirements for both the premarket tobacco application (PMTA) and MRTP. Annual reports for MRTPs contain the cumulative results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.
  • On June 26, 2024, FDA held a TPSAC meeting to discuss these renewal applications.
  • On July 3, 2024, FDA reposted the following files:
  • On July 15, 2024, FDA reposted Annual Reports Part 8.

Public comments on these applications must be submitted to docket FDA-2014-N-1051-0941 on regulations.gov by 11:59 pm ET on Aug. 14, 2024 to ensure they receive consideration by FDA. See the Modified Risk Orders webpage for order letters and decision summaries relevant to these actions.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted. The latest set of application materials from Swedish Match USA, Inc. were made available on July 15, 2024.


Materials and Related Documents

Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.

Additional materials related to the actions include:

Swedish Match USA, Inc. MRTP Application Renewal updated July 15, 2024


Swedish Match USA, Inc. MRTP Application – Authorized on Oct. 22, 2019


* These ZIP files include several individual files. Depending on your Internet connection speed and other factors, it may take a few minutes or up to several hours to download a ZIP file completely.

Note: We are required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (MRTP) applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications. Please visit our Modified Risk Tobacco Products web page for more information.


Additional Resources

 
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